Needle Dispensing and Storing Apparatus for Medicament Delivery Device

ABSTRACT

A flip-open multi-pack assembly is provided which can contain a plurality of new pen needles, such as through the provision of a rectangular or tube-shaped shaped, hinged shell housing, wherein new pen needles can be stored in a plurality of user accessible openings each having a sterility barrier formed, for example, by covers that cover the non-patient end of the openings in which the new pen needles are contained. Used pen needles can be returned and stored in openings accessible by rotatably opening the shell housing. One or more of the openings within first and second opposite ends of the housing shell can be provided with a slidable internal holder within the device and are configured to releasably secure the inner shield of the new pen needle, and to then be pulled forward when the new pen needle is removed and lock at a forward position, and thereby create an interior space, accessible from an opposite end when the hinged housing is opened, for a used pen needle to be inserted and stored.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.13/204,632, filed on Aug. 5, 2011, which claims the benefit of U.S.Provisional Patent Applications Ser. Nos. 61/344,536 and 61/344,539,both filed on Aug. 16, 2010, the disclosures of each of said priorapplications being incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a storage assembly for pen needles ofan injection apparatus. More particularly, the present invention relatesto a storage assembly for storing both new and used pen needles of aninjection apparatus.

BACKGROUND OF THE INVENTION

In certain circumstances, it is desirable to inject medication directlyinto human tissue. Typically, syringes or pen injection devices are usedto inject medicaments into tissue areas, such as the intramusculartissue layer, the subcutaneous tissue layer, and the intradermal tissuelayer. The assembly and operation of such a pen injection device isdescribed in U.S. Pat. No. 7,645,264, issued Jan. 12, 2010, the entirecontents of which is hereby incorporated herein by reference.

Pen injection devices, such as the exemplary drug delivery pen 10 asshown in FIG. 1, provide the user a convenient way to carry a medicamentsupply. All of the required features and components for at least asingle use are provided in the assembly, and in most cases, provide formultiple uses. To do so, the pen 10 typically comprises a doseknob/button 24, an outer sleeve 13, and a cap 21. The cap 21 covers aproximal end of the pen 10 and an injection needle attached thereto, andis used by the user to securely hold the drug delivery pen 10 in a shirtpocket, purse or other suitable location. The dose knob/button 24 allowsa user to set the dosage of medication to be injected, and the outersleeve 13 contains the driving mechanisms and supply, and furtherprovides a gripping surface for the user to grip when injectingmedication.

FIG. 2A is an exploded view of the exemplary drug delivery pen 10 shownin FIG. 1, and typical components contained therein. At a distal end,the dose knob/button 24 is provided and has a dual purpose. The doseknob/button 24 is used to both set the dosage of the medication to beinjected and to inject the dosed medicament via the lead screw 7 andstopper 15 through the medicament cartridge 12, which is attached to thedrug delivery pen through a lower housing 17. In standard drug deliverypens, the dosing and delivery mechanisms are all found within the outersleeve 13 and are not described in greater detail herein as they areunderstood by those knowledgeable of the prior art. The distal movementof the plunger or stopper 15 within the medicament cartridge 12 causesmedication to be forced into the needle 11 of the hub 20. The medicamentcartridge 12 is sealed by septum 16, which is punctured by a septumpenetrating needle cannula 18 located within the hub 20. The hub 20 ispreferably screwed onto the lower housing 17, although other attachmentmeans can be used.

FIGS. 2B and 2C are perspective views of the pen needle of FIG. 2A ingreater detail. As shown in FIG. 2B, the pen needle includes the hub 20disposed at a non-patient end thereof which includes a plurality of ribs64 for engagement with anti-rotation/retaining structures that will bedescribed in greater detail below. In addition, protrusion 68 extendsfrom a patient end of the hub 20 and the patient needle 11 extends fromthe protrusion 68. The septum-penetrating needle cannula 18 disposedwithin the non-patient end of the hub 20 fluidly communicates with thepatient needle 11. Further, as shown in FIG. 2C, the interior of thenon-patient end of the hub 20 includes threads 72 for connection withthe pen injector. FIGS. 2A-2C illustrate one example of a pen needle.

To protect a user, or anyone who handles the drug delivery pen 10, anouter cover 69, which attaches to the hub 20, covers the hub when not inuse. An inner shield 59 covers the patient needle 11 within the outercover 69. The inner shield 59 can be secured to the hub 20 to cover thepatient needle 11 by any suitable means, such as an interference fit ora snap fit. The cap 21 fits snugly against outer sleeve 13 to allow auser to securely carry the drug delivery pen 10. At a time of use, thecap 21, outer cover 69 and inner shield 59 are removed to expose the hub20.

The medicament cartridge 12 is typically a tube sealed at one end withthe septum 16 and sealed at the other end with the stopper 15. Theseptum 16 is pierceable by the septum penetrating cannula 18 in the hub20, but does not move with respect to the medicament cartridge 12. Thestopper 15 is axially displaceable within the medicament cartridge 12 todeliver the desired medicament amount while maintaining a fluid tightseal.

A pen needle, which includes the hub 20, needle 11, outer cover 69 andinner shield 59, is typically used for a single injection and is thendisposed of. Typically, new pen needles are packaged individually anddisposed loose in a container, such as a box or carton. Each pen needleis sealed in a package formed by the outer cover with a label coveringthe opening in the outer cover to identify the pen needle and provide asterility barrier. However, containers of such packaged new pen needlesdo not include means for easily dispensing the new pen needles orcontaining used pen needles. Accordingly, a need exists for a storageassembly that easily dispenses new pen needles and stores both new andused pen needles.

Additionally, existing pen needle containers are configured to store alarge number of packaged new pen needles. The large number of packagednew pen needles causes these containers to be large and bulky, such thatthe containers are not conducive to being carried by the user.Accordingly, a need exists for a storage assembly that is convenientlycarried by a user.

SUMMARY OF THE INVENTION

In accordance with aspects of exemplary embodiments of the presentinvention, the above and other problems are substantially solved byproviding a multi-pack assembly for containing and dispensing one ormore new pen needles, and receiving and then safely and securely storingused pen needles after use.

In accordance with an aspect of the present invention, a housing shellis provided in which a plurality of both new and used pen needles can becontained. An exemplary embodiment of such a shell can be, but is notlimited to, a square shape, a rectangular shape, a round shape, acylindrical shape, or an elliptical shape.

In accordance with another aspect of the present invention, the housingshell can be provided with first and second opposite containment endswhich are attached via a hinge or other flexible member to allow onecontainment end to rotate relative to the opposite containment end suchthat an interior of the housing shell can be accessed by opening, andsecured by closing, of the hinge.

In accordance with another aspect of the present invention, one or bothof the first and second opposite containment ends can comprise one ormore openings, which are configured to contain and store new and usedpen needles which can be accessed by a user with or without opening thehinge.

In accordance with another aspect of the present invention, each of theopenings of the first and second opposite containment ends shouldcomprise a sterility barrier, such as those formed by providing coversthat cover the openings and the non-patient ends of the new pen needlescontained within the housing shell, and which are connected to thehousing shell.

In accordance with another aspect of the present invention, each of theopenings of the first and second opposite containment ends can comprisea tortuous path or inner shield on the patient end of each pen needle,wherein, in an exemplary embodiment of the present invention, the shieldon the patient end of each pen needle is also used to releasably securethe new pen needle in each opening. Removal of the needle is achievedeither through the release of the needle and shield together from thehousing shell, requiring the user to remove the shield before use, orthrough the release of the needle from the shield leaving the shield inthe housing shell.

In accordance with another aspect of the present invention, each of theopenings of the first and second opposite containment ends can passthrough the entire length of each end, respectively, such that one endof the opening can access a new pen needle and an opposite end of theopening can be used to store a used pen needle.

In accordance with another aspect of the present invention, each of theopenings of the first and second opposite containment ends can passthrough the entire length of each ends, respectively, such that thehousing shell can be provided with the hinge that when opened, rotatesthe first and second opposite containment ends of the housing shell andallows interior access to openings of the first and second oppositecontainment ends for receiving and storing used pen needles.

In accordance with another aspect of the present invention, one or moreof the openings within each of the first and second opposite containmentends of the housing shell can be provided with one or more protrusionsfor holding the pen needle in some manner thereby preventing rotation ofthe new pen needle during removal, and preventing rotation of the usedpen needle during insertion, to allow the pen needle to be attached anddetached from the pen and from the housing shell.

In accordance with another aspect of the present invention, the one ormore openings within each of the first and second opposite containmentends of the housing shell can be provided with a slidable internalholder which is configured to releasably secure the inner shield of thenew pen needle, and to then be pulled forward some distance through theopening when the new pen needle is removed and lock at a forwardposition, and thereby create a space in the opening, opposite the newpen needle removal side and accessible from the opposite, hinged side,for a used pen needle to be inserted and stored.

In accordance with another aspect of the present invention, a multi-packassembly for containing and then dispensing one or more new pen needles,and receiving and then safely and securely storing used pen needles, canbe provided wherein during an exemplary use a user first grips an outersurface of the housing shell and removes a cover to access a new penneedle secured within the covered opening of one of the first or secondcontainment ends of the assembly. The user can then attach theaccessible new pen needle to the drug delivery pen, such as through theuse of a threading action, as the new pen needle is releasably securedwithin the opening and prevented from rotating. The user can then pullthe new pen needle from the assembly to remove the new pen needle, andsuch removal motion serves to pull the slidable internal holdercomponent within the multi-pack assembly forward, thereby creating aspace at an opposite end for the subsequent used pen needle to beinserted and stored. The user can then simply remove the shield that isshielding the new pen needle and perform the injection. If the shield isleft in the housing shell during removal, the user can simply performthe injection.

In accordance with another aspect of the present invention, a multi-packassembly for containing and then dispensing one or more new pen needles,and receiving and then safely and securely storing used pen needles, canbe provided wherein upon completion of the injection, the user can openthe multi-pack assembly at the hinged point between the opposite firstand second containment ends to allow interior access to the createdopening for receiving and storing the used pen needle, and place theused pen needle into the open space, engaging the anti-rotation feature,and unscrewing the pen injection device from the used pen needle andleaving the used pen needle in the opening of the multi-pack assembly.After the used pen needle has been unscrewed from the device, the usercan then simply close the shell of the multi-pack assembly for storage.

In accordance with another aspect of the present invention, a multi-packassembly for containing and then dispensing one or more new pen needles,and receiving and then safely and securely storing used pen needles, canbe provided by a device including a plurality of pen needlesindividually contained in a tube-shaped structure. A sterility barrierfor each new pen needle should be provided and is formed by covers thatcover a non-patient end of each pen needle. Each pen needle is containedin a separate, individually accessible section or unit of the tubestructure, and adjacent units of the tube structure are hingedlyconnected.

These and other objects, advantages, and salient features of theinvention will become apparent from the following detailed description,which, taken in conjunction with the annexed drawings, disclosesexemplary embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The above benefits and other advantages of the various embodiments ofthe present invention will become more apparent from the followingdetailed description of exemplary embodiments of the present inventionand from the accompanying figures, in which:

FIG. 1 is a perspective view of an assembled drug delivery pen for usewith exemplary embodiments of the present invention;

FIG. 2A is an exploded perspective view of the components of the drugdelivery pen of FIG. 1;

FIGS. 2B and 2C are perspective views of the pen needle for use with thedrug delivery pen of FIG. 1;

FIG. 3 is a perspective view of a flip-open multi-pack assemblyaccording to an exemplary embodiment of the present invention;

FIG. 4 is a perspective view of the multi-pack assembly of FIG. 3 openedat the hinge according to an exemplary embodiment of the presentinvention;

FIG. 5 is a sectional view of the device of FIG. 3 illustratingindividual needle assemblies in at least one of the first and secondopposite containment ends according to an exemplary embodiment of thepresent invention;

FIG. 6 is an enlarged sectional view of the device of FIG. 3illustrating a track of motion of the removal of one new pen needleassembly from the multi-pack assembly according to an exemplaryembodiment of the present invention;

FIG. 7 is an enlarged sectional view of the device of FIG. 3 with onenew pen needle removed according to an exemplary embodiment of thepresent invention;

FIG. 8 is an enlarged sectional view of the device of FIG. 4illustrating used pen needle return and storage in the multi-packassembly according to an exemplary embodiment of the present invention;

FIG. 9 is a perspective view of a multi-pack assembly havinguser-separable packs according to another exemplary embodiment of thepresent invention;

FIG. 10 is a perspective view of a flip-open multi-pack assemblyaccording to another exemplary embodiment of the present invention;

FIG. 11 is an enlarged sectional view of the device of FIG. 10 accordingto an exemplary embodiment of the present invention;

FIG. 12 is a perspective view of the device of FIG. 10 preparing one newpen needle for removal according to an exemplary embodiment of thepresent invention;

FIG. 13 is a perspective view of the device of FIG. 10 preparing anothernew pen needle for removal according to an exemplary embodiment of thepresent invention;

FIG. 14 is a perspective view of the device of FIG. 10 with one new penneedle removed according to an exemplary embodiment of the presentinvention;

FIG. 15 is an enlarged perspective view of a dispensing end of a firststorage unit of the device of FIG. 10 according to an exemplaryembodiment of the present invention;

FIG. 16 is an end view of the dispensing end of the first storage unitof FIG. 15 according to an exemplary embodiment of the presentinvention; and

FIG. 17 is a perspective view of a sterility cover according to anexemplary embodiment of the present invention.

Throughout the drawings, like reference numbers will be understood torefer to like parts, components and structures.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

As noted above, new pen needles are typically packaged individually anddisposed loose in a container, such as a box or carton. Each pen needleis sealed in a package formed by the outer cover with a label coveringthe opening in the outer cover to identify the pen needle and provide asterility barrier. However, containers of such packaged new pen needlesdo not include means for easily dispensing the new pen needles orcontaining used pen needles. Additionally, existing pen needlecontainers are configured to store a large number of packaged new penneedles. The large number of packaged new pen needles causes thesecontainers to be large and bulky, such that the containers are notconducive to being carried by the user.

Current pen needles are sold individually packaged inside a plasticcover, with a label adhered to the cover to identify the needle andprovide a sterility barrier. However, a more convenient system andmethod is desired including a multiple needle package configuration thatstores and provides new pen needles for use, and includes some provisionfor receiving and containing used pen needles after use. The exemplaryembodiments of the present invention address these and other needs byproviding a multi-pack assembly including multiple new pen needles inuser accessible openings of the assembly, wherein covers or otherenclosures are provided or positioned to enclose each new pen needleinside the user accessible openings of the assembly. In one or moreexemplary embodiments, hinged access to an opposite end of theaccessible openings is provided to receive and store used pen needlesafter removal of the new pen needles. In one or more other exemplaryembodiments, hinged access to an opposite end of the accessible openingsis provided to access a next new pen needle.

In an exemplary embodiment of the present invention shown in FIGS. 3-8,a multi-pack assembly is provided for storing and then dispensing one ormore new pen needles from spaces accessible from one end, and receivingand containing used pen needles in substantially the same spacesaccessible from an opposite end once the space is opened by the removalof the new pen needle. The embodiments include a flip-open multi-packassembly which can contain a plurality of new pen needles, such asthrough the provision of a rectangular shaped, hinged shell housing,wherein new pen needles can be stored in a plurality of covered, useraccessible openings, each having a sterility barrier formed, forexample, by covers that cover the user accessible openings andnon-patient ends of the new pen needles contained therein which arereleasably secured to an inner portion of each opening of the shell viaa tortuous path shield on the patient end of each new pen needle.Removal of the needle is achieved either through the release of theneedle and shield together from the housing shell, requiring the user toremove the shield before use, or through the release of the needle fromthe shield, leaving the shield in the housing shell. When left on theneedle, the shield provides sterility to the patient end, via thetortuous path, but when left in the housing shell, it does not requirethe user to remove it after attachment of the needle.

The exemplary hinged shell housing of embodiments of the presentinvention include a substantially enclosed housing having up to a firstand second containment end connected via a hinge or other flexiblemember, and which are configured to rotate relative to each other. Sucha hinge, when opened, allows interior access to the openings within oneor both of the first and second containment ends of the housing forreceiving and storing used pen needles. One or more of the openingswithin each of the first and second opposite containment ends of thehousing can be provided with one or more protrusions for preventingrotation of the new pen needle contained therein, or the used pen needleinserted therein, to allow the pen needle to be attached and detachedfrom the pen and from the housing shell. Further, one or more of theopenings within each of the first and second opposite containment endsof the housing shell can be provided with a slidable internal holderwhich is configured to releasably secure the shield of the new penneedle, and to then be pulled forward when the new pen needle is removedand lock at a forward position, and thereby create a space, accessiblefrom the opposite, hinged end, for a used pen needle to be inserted andstored.

Pen needles of the exemplary embodiments can be manufactured usingexisting processes and subsequently assembled into the housings of theexemplary embodiments of the present invention, thereby simplifying themanufacturing process. The overall size of the exemplary embodiments ofthe present invention is minimized by allowing used pen needles to bestored in substantially the same spaces previously used to store the newneedles. Further, the exemplary embodiments of the present invention canbe constructed having a size and shape, and contoured edges, to increasethe comfort of the user during transportation, such as in a user'spocket.

An exemplary hinged shell housing 100 is shown in FIG. 3. In a firstexemplary embodiment of the present invention, the housing 100 comprisesa first and second containment end, 102 and 104, respectively, that arerotatably joined at a point 106. In the exemplary embodiment shown, thefirst and second containment ends 102 and 104 are rotatably joined atthe point 106 using a flexible member, such as a hinge including but notlimited to, a barrel hinge, living hinge or other suitable hingemechanism. In yet other embodiments of the present invention, the firstand second containment ends 102 and 104 can be snap fit together at thepoint 106 using a detent and recess arrangement (not shown). Still otherembodiments of the present invention can use any number of otherconnection means between the first and second containment ends 102 and104 of the housing 100. Further, exemplary embodiments of the presentinvention can comprise a single containment end, either 102 or 104, anda simple hinged cover (not shown) in place of the omitted containmentend.

One or both of the first and second containment ends 102 and 104 of thehousing 100 can provide access to new pen needles contained therein viacovered openings 108-118. Each of the openings 108-118 of the first andsecond opposite containment ends 102 and 104 pass through the entirelength of each end, respectively, such that one end of the opening canbe used to access a new pen needle contained in the opening, and anopposite end of the opening can be used to store a used pen needle. Theshell housing 100 can be provided with a hinge that when opened, rotatesthe first and second opposite containment ends 102 and 104 of thehousing and allows interior access to openings of the first and secondopposite containment ends for receiving and storing used pen needles.

A sterility barrier to each new pen needle in openings 108-118 should beprovided via covers 120-130 which are disposed to cover the openings108-118 and the new pen needles contained therein. The sterilitybarriers can be constructed of paper, metal foil, plastic or similarmaterials, and can be attached to cover the openings via adhesive, heatseal, ultrasonic welding or other suitable means, and each of the covers120-130 can be provided with a tab element 132-142 to allow a user toeasily grasp and remove the tabs and covers 120-130. In an exemplaryembodiment of the present invention, the tab elements 132-142 can beprovided with a different degree of adhesion, to allow a user to easilygrasp and lift the tabs and covers 120-130. The covers 120-130 can befurther provided with colors, marks or other indicators of the penneedle contained therein.

FIG. 4 illustrates the exemplary shell housing 100 that has been openedto show the facing surfaces of the first and second containment ends 102and 104 of the shell housing 100, and the interior access to theopenings. In the condition illustrated in FIG. 4, no spaces have beenyet created in the openings for the placement of used pen needles. Thatis, the condition illustrated in FIG. 4 represents an exemplary shellhousing 100 in which each opening is containing a new pen needle. It isthe removal of at least one new pen needle that creates an opening spaceaccessible from the interior for the insertion of the used pen needle.

In the exemplary embodiment shown, a hinge 150 is provided at the point106 between the first and second containment ends 102 and 104. The hinge150 can comprise any number of rotatable elements such as a barrelhinge, living hinge or other rotatable mechanism. Further, where thehinge itself is not sufficiently biased to hold the shell housingclosed, one or more securing tabs 101 and 103 can be provided on atleast one of the first and second containment ends 102 and 104 to securethe closure between the first end 102 of the housing 100 and the secondend 104 of the housing 100. In an exemplary embodiment shown, thesecuring tabs 101 and 103 can comprise a deflectable member having aninclined detent at an end thereof, which can be deflected by contactwith corresponding openings 105 and 107 provided in at least one of thefirst and second ends 102 and 104 opposite the hinge 150 of the housing100, and releasably secured therein. In yet other embodiments of thepresent invention, other elements such as a biased hinge or press fitcan be used to secure the closure between the first end 102 of thehousing 100 and the second end 104 of the housing 100.

As also illustrated in FIG. 4, the facing surfaces of the first andsecond containment ends 102 and 104 of the housing 100 comprise interioraccess to the openings 108-118 for receiving and storing used penneedles. Specifically, a series of openings 152-162 provide interioraccess to the openings 108-118 of the first and second oppositecontainment ends for receiving and storing used pen needles afterremoval of one or more of the new pen needles that are accessible afterremoval of the covers 120-130 at the opposite ends of the first andsecond containment ends 102 and 104. In an exemplary embodiment of thepresent invention, the openings 108-118 and 152-162 are substantiallyround and contain therein slidable internal holders 164-174 whichseparate the openings 108-118 and 152-162 and provide a mechanism tosecure the new pen needles at one side, and secure used pen needles wheninserted at an opposite side.

As shown in greater detail in FIG. 5, slidable internal holders 164-174can be provided and are configured to releasably secure the shield 59 ofthe new pen needle, and to then be pulled forward when the new penneedle is removed and lock at a forward position, and thereby create aninterior space, accessible from the facing surfaces of the first andsecond ends 102 and 104 of the housing 100, for a used pen needle to beinserted and stored. To do so, the slidable internal holders 164-174 canalso be provided and configured to secure the used pen needle wheninserted into the interior space, accessible from the facing surfaces ofthe first and second containment ends 102 and 104 of the housing 100.

The slidable internal holders 164-174 have sides facing the openings108-118 and which releasably secure the capped patient end side of thenew pen needles, and side facing interior openings 152-162 to secure theused pen needle when inserted, and provide separation members betweeneach of the spaces. As shown in FIGS. 4 and 5, each of slidable internalholders 164-174 have a flat second side which is configured tosubstantially fill the openings 152-162 and are trapped within each ofopenings 152-162 by a series of tabs 188-210 which extend a distancefrom an inner circumference of the openings 152-162 to prevent escape ofthe slidable internal holders 164-174. Further, as shown in FIG. 6, eachof tabs 188-210 are extended from ribs 314 (repeated in each opening,but only one shown for illustrative purposes) which are disposed alongan inner wall of each of the openings 152-162 and which guide a notch316 (repeated on each slidable internal holder, but only one shown forillustrative purposes) in each of the slidable internal holders 164-174.

Further, each of the second ends of the slidable internal holders164-174 comprise substantially circular apertures 318-328 as shown inFIG. 5 to provide an entrapment opening for the used pen needles, andwhich are disposed directly opposite from substantially circularapertures 290-294 (repeated on each slidable internal holder, but onlythree shown for illustrative purposes) to provide an entrapment openingfor the new pen needle inner shield 59 at the first side of eachslidable internal holders 164-174 as described in greater detail below.

As also shown in FIGS. 4 and 5, each of the second sides of the slidableinternal holders 164-174 have one or more notches 212-234 to provide adegree of clearance for inclined projections 236-246 (repeated on eachslidable internal holder, but only six shown for illustrative purposes)disposed at ends of flexible members 260-270 (repeated on each slidableinternal holder, but only six shown for illustrative purposes) and whichare elastically biased toward contact with an inner wall of each ofopenings 152-162. Such contact serves a number of purposes, includingbut not limited to, slightly opposing movement of the slidable internalholders 164-174. Further, as the slidable internal holders 164-174 aremoved from a position as shown in FIG. 5, to a position shown in FIG. 6(in regard to the single example shown), as pulled by the removal of thenew pen needle once attached to a pen device (not shown), the inclinedprojections 236-246 contact shoulders 330-340 (present in each opening,but only six shown for illustrative purposes) near an end of each ofopenings 152-162 and at a point near openings 108-112, and are deflectedinward until pulled past the shoulders 330-340 (present in each opening,but only six shown for illustrative purposes) disposed upon an innerwall of the respective openings. At this point, the inclined projections236-246 return to a non-deflected state into openings 342-352 (presentin each opening, but only six shown for illustrative purposes) and nowsecure the slidable internal holders 164-174 at the opposite end of theopenings 152-162 and at a point near openings 108-112. Once in such aposition, for example, the shield 59 attached to the pen needle, ispulled free with the pen needle from the circular aperture 290 of thefirst end of the slidable internal holder 164 as shown in FIG. 6 (inregard to the single example shown), or the pen needle is pulled freefrom the shield 59 which is left in the housing shell.

The first end of each of the slidable internal holders 164-174 comprisecentral apertures 290-294 (present on each slidable internal holder, butonly three shown for illustrative purposes) configured to releasablysecure the new pen needle inner shield 59 within each of the openings108-118. To do so, an exemplary embodiment of the present invention canprovide such central apertures 290-294 (present on each slidableinternal holder, but only three shown for illustrative purposes) as asubstantially circular opening of a diameter and depth sufficient totightly hold the new pen needle shield 59 when in position, but releasethe new pen needle shield 59, still attached to the new pen needle, whenthe pen needle is removed. That is, removal of the needle is achievedeither through the release of the needle and shield 59 together from thehousing shell, requiring the user to remove the inner shield before use,or through the release of the needle from the shield 59 leaving theshield 59 in the housing shell. Relief openings 302-312 (present on eachslidable internal holder, but only six shown for illustrative purposes)can be provided surrounding each central apertures 290-294 and provide aspace for deflection of the members 260-282 and inclined projections of236-258.

As noted above, each of the passages between openings 152-162 andopenings 108-118 include an inner wall upon which members 314 are usedto guide the slidable internal holders 164-174 through contact with thenotches 316 in each of the slidable internal holders 164-174. In anexemplary embodiment of the present invention, the members 314 areformed as a rail disposed on the inner wall of the passages betweenopenings 152-162 and openings 108-118. In doing so, the members 314 areused to guide the slidable internal holders 164-174 through contact withthe notches 316 in each and are also provided as protrusions forpreventing rotation of the new pen needle and the used pen needlecontained therein, or inserted therein, to allow the pen needle to beattached and detached from the pen and from the housing shell.Specifically, where the central apertures 290-294 releasably secure thenew pen needle shield 59 within each of the openings, the members 314and notches 316 prevent rotation of the new pen needle to allow the newpen needle to be attached and detached from the pen device and from thehousing shell. In a similar manner, where the apertures 318-328 securethe used pen needles within each of the openings, the members 314 andnotches 316 prevent rotation of the used pen needle to allow the usedpen needle to be detached from the pen while held in the housing shell.

Further, at a point near the end of slidable travel of the slidableinternal holders 164-174, the inner wall of the openings comprises theshoulders 330-340 to contact similar shoulders 354 (present on eachslidable internal holder, but only one shown for illustrative purposes)of the slidable internal holders 164-174 and stop slidable travel in afirst (forward) direction. However, the inclined projections 244 and 246are deflected and pass over the shoulders 338 and 340, return to anon-deflected state into openings 350 and 352, and are then captured inthe openings 350 and 352 provided in the inner wall and secure theslidable internal holders 164-174 at the opposite end of the openingsand prevent slidable travel in a second (rearward) direction. In thisposition, the slidable internal holders 164-174 are prevented fromeither further forward or rearward travel, and cannot be rotated.

As shown in FIGS. 6 and 7, once travel of the slidable internal holders164-174 is stopped in this manner, the new pen needle is pulled free ofthe housing 100 and the shield 59 can then be removed for device usage,or the needle can be released from the shield 59 which is left in thehousing shell. Further, once travel of the slidable internal holders164-174 is stopped in this manner, the used pen needle can be placedwithin the now open space provided by the movement of the slidableinternal holders 164-174 during new pen needle removal, engaging theapertures 318-328 to secure the used pen needle within the openings andthe housing closed for storage.

The new pen needle removal operations can be performed with the housing100 open or closed, as the new pen needle is accessible via the coveredopenings 108-118 at the ends of the housing opposite the hinged point.FIG. 8 illustrates the placement of the used pen needle back into thehousing 100 for storage. As shown in FIG. 8, the housing 100 is firstopened so a user can access an interior space provided in one of theopenings 152-162, created by the removal of the new pen needle asdescribed above, such that the slidable internal holder is now deeplypositioned within the opening. Accordingly, the user can insert the usedpen needle into the opening 156 and engage the second end of theslidable internal holder (not shown). Specifically, the used pen needleis engaged with the second end of the slidable internal holder therebysecuring the used pen needle in the opening 156, and the pen isunscrewed or otherwise detached from the used pen needle now securelyheld deeply within the opening 156. The housing 100 can then be closedand the used pen needle safely stored, while new pen needles are alsosafely stored and accessible in the same housing.

As noted above, FIGS. 2B and 2C are perspective views of the pen needleof FIG. 2A wherein the pen needle includes the hub 20, protrusion 68 andpatient needle 11. The septum-penetrating needle cannula 18 disposedwithin the non-patient end of the hub 20 fluidly communicates with thepatient needle 11, and the interior of the non-patient end of the hub 20includes threads or other features 72 for connection with the peninjector. In these or other exemplary embodiments of the presentinvention the pen needle can omit one or more of the above features aslong as sterility of both the patient and non-patient ends of thecannula is maintained. For example, an exemplary pen needle can also beprovided having a hub and cannula assembly only.

In another exemplary embodiment of the present invention, the multi-packassembly 100 can be constructed of one or more of a polycarbonate,polyethylene, polypropylene and acrylonitrile butadiene styrenematerial, but is not limited thereto. Further, the multi-pack assembly100 and/or the covers 120-130 can be color-coded or otherwise marked tosimplify identification of the new pen needles stored therein. Stillfurther, the exemplary embodiment shown comprises first and secondcontainment ends, 102 and 104, respectively, that are rotatably joinedat a point 106, but in other embodiments of the present invention thefirst and second containment ends can be non-rotatably joined, or onlyone containment end can be provided and a hinged cap provided in placeof the omitted containment end.

In yet other embodiments of the present invention, the multi-packassembly can be divided by the user into sets of two, four, or similarsets thereby allowing the user to select the number of new pen needlesthat are to be carried. FIG. 9 is a perspective view of a multi-packassembly having such user-separable containment ends according toanother exemplary embodiment of the present invention. In the exemplaryembodiment show, the multi-pack assembly 200 is perforated betweencontainment ends to allow a user to tear off, or break away, twocontainment ends along the hub central axis, while still maintainingsterility as well as the ability to store new and used pen needles asdescribed above. In such an embodiment, a perforated thin section 202 isprovided between each containment end 204 to allow such user separation.

In yet other embodiments of the present invention, the multi-packassembly can be enlarged by the user by adding additional sets of two,four, or similar sets of containment ends, thereby allowing the user toselect the number of new pen needles that are to be carried. Forexample, the multi-pack assembly can have connectors between containmentends to allow a user to disconnect or connect additional containmentends, while still maintaining sterility as well as the ability to storenew and used pen needles as described above. In such an embodiment, amale detent can be provided on one side of each containment end, and afemale opening can be provided on an opposite side of each containmentend, such as a rectangular member and opposite opening, to allow suchuser separations and combinations in a snap-fit manner. Alternatively, asliding connector mechanism could be used to attach and detachcontainment ends of needles, such as through the provision of a fail andguide, or dovetail mechanism.

Further, in these or other exemplary embodiments of the presentinvention, a lock-out system and method can be provided such that afterthe use of the final needle, the user can manually lock the housing(i.e., manually lock the housing closed) to allow for safe disposal. Forexample, a manual lock can be provided on the needle storage assembly,thereby allowing the user to manually lock the storage assembly afterfinal use to allow for safe disposal thereof and prevent reuse. In theseand other exemplary embodiments of the present invention, an emergencyneedle feature can also be provided wherein at least one new or usedneedle can remain accessible, such that the user has access to at leastone of the new or used needles for use in case of an emergency.Alternatively, in yet other embodiments of the present invention, onlyone needle can be provided as always accessible, thereby providing anavailable needle for use in case of emergency. The other pen needles canbe locked into the storage assembly and can no longer be accessible.

In yet another exemplary embodiment of the present invention, analternate design can be provided to simplify the inner mechanics of thedevice and for sterility barrier issues. For example, the device cancomprise only one open end for each pen needle. The opening can be onthe inside and accessed only when the hinge of the device is opened up,or the opening can be on the outside where no living hinge would berequired. Further, a cover can be provided on either of these openings,and the new pen needle would be removed, and the used pen needlereturned to the same space. In such an exemplary embodiment, much of theinner elements and mechanics of the device described above could beeliminated, thereby simplifying the manufacturing processes.

In the exemplary embodiment of the present invention, a sterilitybarrier is provided on the patient end of the pen needle, such asprovided by the tortuous path of the shield, but such tortuous path ofthe patient end of the pen needle can be improved. For example, a solidpiece can be provided at the end of the patient end of each pen needlewherein such an exemplary solid piece can be configured to fit flushagainst the wall of the cavity or openings in the housing shell, and thesolid piece can be sealed or otherwise secured to the inner wall of thehousing shell in some manner, such as through a heat sealing operationor adhesive, to secure the solid piece to the wall. Thereafter, applyinga limited pulling force can then be used to break the seal of the solidpiece from the wall and allow the new pen needle to be pulled out of thecavity of the housing shell. Such an exemplary seal can be configured toprovide or supplement the sterility barrier on the patient end.

In yet another exemplary embodiment of the present invention, the devicecan include the placement of a cover on each end of the individualcavities to provide a sterility barrier on each end of the pen needle.In this exemplary embodiment, the cover on the non-patient contactingend would have to be removed prior to attachment of the pen needle tothe pen. Then, the cover on the patient side of the cavity would have tobe removed prior to returning the used pen needle to the device.

As noted above, in accordance with another aspect of the presentinvention, a multi-pack assembly for containing and then dispensing oneor more new pen needles, and receiving and then safely and securelystoring used pen needles, can be provided by a device including aplurality of pen needles individually contained in a tube-shapedstructure. A sterility barrier for each new pen needle should beprovided and is formed by covers that cover a non-patient end of eachpen needle, and each pen needle can be contained in a separate,individually accessible section or unit of the tube structure, andadjacent units of the tube structure can be hingedly connected.

FIG. 10 is a perspective view of a flip-open multi-pack assemblyaccording to another exemplary embodiment of the present invention, andFIG. 11 is an enlarged sectional view of the device of FIG. 10. FIG. 10is a perspective view of a flip-open multi-pack tube assembly 400 inaccordance with an embodiment of the present invention. The assembly 400includes a plurality of pods or storage units for storing a plurality ofpen needles 410. For example, as shown in FIG. 10, the assembly 400includes first through fifth storage units 404, 408, 412, 416 and 420.The plurality of pen needles are individually contained within therespective storage units 404-420. The hingedly connected individualstorage units 404-420 replace the inner shield and the outer cover ofFIG. 2A, in addition to other functions as will be described. However,in other exemplary embodiments the inner shields can be employed incombination with pen needles and storage units 404-420.

As shown in FIG. 10, the first storage unit 404, unlike the remainingstorage units, has a lid 424 which is connected to the first storageunit 404 by a lid hinge 428. Additionally, a hinge 432 connects each ofthe remaining storage units 408-420 to its adjacent storage unit. Aspartially shown in FIG. 10, according to one embodiment, the lid hinge428 and the hinges 432 are alternately disposed on opposing sides of theassembly 400 so that, as described in greater detail below, each storageunit is opened in an opposing direction than its adjacent storageunit(s). However, in yet other exemplary embodiments of the presentinvention, the lid hinge 428 and the hinges 432 may be all disposed onone side without departing from the scope of the present invention. Thelid hinge 428 and the hinges 432 may be, for example, living hinges. Aliving hinge is not described in greater detail herein, as it would beunderstood by those knowledgeable of the art.

According to one embodiment, sterility covers 436 provide a sterilitybarrier for each of the storage units 404-420. As will be described ingreater detail below, when each of the storage units 404-420 isaccessed, the sterility cover 436 is removed to access the sterile penneedle contained therein. The sterility covers should be provided tocover the openings and the new pen needles contained therein. Thesterility barriers can be constructed of paper, metal foil, plastic orsimilar materials, and attached to cover the openings via adhesive, heatseal, ultrasonic welding or other suitable means, and each of the coverscan be provided with a tab element to allow a user to easily grasp andremove the tabs and covers. In an exemplary embodiment of the presentinvention, the tabs of the sterility covers 436 can be provided with adifferent degree of adhesion, to allow a user to easily grasp and liftthe tabs. The sterility covers 436 can be further provided with colors,marks or other indicators of the pen needle contained therein.

FIG. 11 is a perspective view in cross-section taken along line A-A inFIG. 10 of the assembly 400. As shown in FIG. 11, each of the storageunits 404-420 encapsulates a pen needle 410 with the non-patient end ofthe pen needle 410 being oriented toward the top of the storage unit.Additionally, as shown in FIGS. 10 and 11, a plurality of closuremembers or tabs 440 are disposed on the storage units, each closuremember 440 selectively engaging an adjacent storage unit (408-420) toclose the interior of the adjacent storage unit (408-420). Conversely,as will be described in greater detail below, each closure member 440selectively disengages from the adjacent storage unit (408-420) toprovide access to the interior of the adjacent storage (408-420) unit byrotation about the connecting hinges 432.

According to one embodiment as shown in FIG. 11, closure members 440 aredisposed in pairs on opposing sides of the first through fourth storageunits 404-416. Additionally, as will be described in greater detailbelow, each of the closure members 440 has an engaging member 444disposed at a first end thereof for selectively engaging and disengagingfrom the adjacent storage unit (408-420). Further, as will be describedin greater detail below, each closure member 440 has a user portion 448disposed at a second end thereof for interaction with a user. Moreover,as shown in FIG. 11, each of the closure members 440 is connected to itscorresponding storage unit (404-416) via a web 452. The web 452 providesstructural connection between the closure members 440 and thecorresponding storage units, and is also sufficiently flexible to act asa pivot and allow rotation of the closure members 440 relative to thecorresponding storage units.

With reference to FIGS. 12-14, the operation of the assembly 400 willnow be described. FIGS. 12 and 13 are perspective views of the device ofFIG. 10 preparing a new pen needle for removal, and FIG. 14 is aperspective view of the device of FIG. 10 with a new pen needle removedaccording to an exemplary embodiment of the present invention.

As shown in FIG. 12, to access the pen needle 410 in the first storageunit 404, the user rotates lid 424 about lid hinge 428 to reveal thesterility cover 436. As shown in FIG. 12, the sterility cover 436includes a tab portion 456 and a closure portion 460. Subsequent toopening the lid 424, the user grasps and lifts the tab portion 456 topeel off the cover portion 460, which is adhered to the first storageunit 404. Removal of the sterility cover 436 provides access to thenon-patient end of the pen needle 410 contained within the first storageunit 404. The user then connects a pen injector 450 to the non-patientend of the pen needle 410 for use.

After use, the user returns used pen needle 410 to the same storage unitit came from. In the example above, the user removed the pen needle 410from the first storage unit 404, and thus can return the used pen needle410 to the first storage unit 404, disengage the pen injector 450 fromthe pen needle 410, and close first storage unit 404 by rotating the lid424 about the lid hinge 428.

Subsequent removal of new pen needles, in contrast to accessing the penneedle in the first storage unit 404, by accessing a pen needle 410 inany of the second through fifth storage units 408-420 is accomplishedvia a different method. For example, as shown in FIG. 13, to access thepen needle 410 in the third storage unit 412, the user grasps andsqueezes the user portions of closure members 440 of the second storageunit 408. Because of the flexibility of the web 452, the squeezingrotates the closure member 440 with respect to the second storage unit408. More specifically, the squeezing rotates the engaging members 444outwardly with respect to the second storage unit 408, therebydisengaging the engaging members 444 from the third storage unit 412.

As shown in FIG. 13, the third storage unit 412 has a pair of retainingmembers 464 corresponding to the engaging members 444 of the closuremembers 440 of the second storage unit 408. According to one embodiment,the retaining members 464 are bosses extending from opposing sides ofthe third storage unit 412. In yet other exemplary embodiments, theretaining members 464 are detents recessed from opposing sides of thethird storage unit 412. When closed, the hook-like engaging members 444engage the retaining members 464. However, when the closure members 440are squeezed and rotated by the user, the engaging members 444 releasefrom the retaining members 464. As the closure members 440 are disposedon the first through fourth storage units 404-416, correspondingretaining members 464 are disposed on the second through fifth storageunits 408-420.

As shown in FIG. 13, after disengaging the closure members 440 from theretaining members 464, the user rotates the first and second storageunits 404 and 408 away from the third through fifth storage units412-420 via hinge 432. Subsequently, similar to accessing the pen needle410 in the first storage unit 404, the user removes the sterility cover436, and connects the pen injector 450 to the non-patient end of the penneedle 410 for use as shown in FIG. 14. After use, the user then returnsthe pen needle 410 to the third storage unit 412, disconnects the peninjector 450 from the pen needle 410, and closes the assembly 400 byrotating the first and second storage units 404 and 408 about the hinge432 until the engaging members 444 of the closure members 440 of thesecond storage unit 408 engage the retaining members 464 of the thirdstorage unit 412.

FIG. 15 is an enlarged perspective view of a dispensing end of the firststorage unit 404 and FIG. 16 is an end view of the dispensing end of thefirst storage unit 404. For clarity, the lid 424 and the pen needle 410are not illustrated in FIGS. 15 and 16. As shown in FIGS. 15 and 16, thedispensing end of the first storage unit 404 includes a plurality ofanti-rotation/retaining structures 468. Only the first storage unit 404is shown, but each of the storage units 404-420 includes suchanti-rotation/retaining structures 468. At the dispensing end of thefirst storage unit 404, the anti-rotation/retaining structures 468 workin conjunction with the hub of a pen needle to prevent rotation of thepen needle when the pen needle is in a dispensing position. For example,when the pen needle is in the dispensing position within the firststorage unit 404 and the anti-rotation/retaining structures 468 areengaged with the ribs 64 (see FIGS. 2B and 2C) of hub 20, theanti-rotation/retaining structures 468 prevent the pen needle fromrotating and permit the user to connect a pen injector or a medicamentcartridge to the hub by threading the pen injector or medicamentcartridge into the threads 72 of the hub 20. While preventing rotationof the pen needle during connection to the pen injector, subsequent tothe connection, the fit between the anti-rotation/retaining structures468 and the pen needle permits the user to axially withdraw the combinedpen injector and pen needle from the first storage unit 404.

Conversely, when returning the used pen needle to the first storage unit404, the user axially inserts the pen needle into the first storage unit404 to engage the ribs 64 of the hub 20 with the anti-rotation/retainingstructures 468. Subsequent to the engagement, the user rotates the peninjector to unthread the pen injector from the threads 72 of the hub 20,thereby disengaging the pen injector from the pen needle. The fitbetween the anti-rotation/retaining structures 468 and the pen needleprovides some resistance to removal of the pen needle from the firststorage unit 404 and prevents the pen needle from simply falling out ofthe first storage unit 404 subsequent to removal of the sterility cover436.

FIG. 17 is a perspective view of another embodiment of a sterility cover136 covering the dispensing end of the first storage unit 404. Whereas,for example, in FIG. 12, the tab portion 456 of the sterility cover 436is disposed on the outside of the assembly 400, in FIG. 17, the tabportion 472 folds over on top of cover portion 460 and is enclosed bythe cover 424 when the cover is closed. Similarly, although not shown,the adjacent storage units 404-416 enclose the tab portions 472 of theremaining sterility covers 436 when closed. In yet other exemplaryembodiments of the present invention, the sterility covers 436 can besecured by, and/or removed by the action of opening the cover 424 and/orthe adjacent storage units 404-416. In yet other exemplary embodimentsof the present invention, a circumferential sterility cover can beprovided and can be peeled off prior to access to the individual penneedles. In still other exemplary embodiments of the present invention,the sterility cover 436 can be omitted, and the closure betweenindividual storage units 404-420, as well as the closure between thecover 424 and the first storage unit 404, can be a form-fit orinterference-fit tortuous path, thereby providing the sterility barrier.As known to those skilled in the art, a tortuous path closure can bedefined as a barrier to airborne microorganisms, accomplished bycreating a convoluted pathway to the product, for example, by labyrinthpaths or a screw-threaded closure.

Because patients are accustomed to using and transporting pen injectors,one advantage of the exemplary embodiments of the present invention isto provide a compact, convenient apparatus for containing and dispensingnew pen needles, and storing used pen needles, in an easy to transportassembly. A lock can be provided on the pen needle storage assemblies,thereby allowing the user to manually lock the storage assembly to allowfor safe disposal thereof. Preferably, such locks become functional onlyafter the last pen needle has been used, but embodiments are not limitedthereto. In another exemplary embodiment of the present invention, oneor more used pen needle remains accessible such that the user has accessto a used pen needle in case of an emergency. The other pen needles canalso be accessible or locked into the storage assembly.

The foregoing embodiments and advantages are merely exemplary and arenot to be construed as limiting the scope of the present invention.Various modifications, alternatives and variations will be apparent tothose of ordinary skill in the art, and are intended to fall within thescope of the invention as defined in the appended claims and theirequivalents.

1. The method as recited in claim 16, wherein: said first and secondopposite containment ends are rotatably attached to allow onecontainment end to rotate relative to said opposite containment end suchthat an interior surface of said assembly can be accessed by saidrotation; and said containment ends comprise one or more adjacentopenings accessible from an outer surface of said assembly, and one ormore openings accessible from said interior surface of said assemblyafter said rotation, which are configured to contain and store new andused pen needles.
 2. The method as recited in claim 1, wherein each ofsaid openings of said first and second opposite containment endscomprises a sterility barrier.
 3. The method as recited in claim 1,wherein each of said openings of said first and second oppositecontainment ends can accommodate an inner shield for a patient end of apen needle, configured to releasably secure said pen needle in eachopening.
 4. The method as recited in claim 1, wherein each of saidopenings of said first and second opposite containment ends passesthrough an entire length of each containment end, respectively, suchthat one end of said opening can be used to access a new pen needlecontained therein, and an opposite end of said opening can be used tostore a used pen needle.
 5. (canceled)
 6. The method as recited in claim1, wherein one or more of said openings within each of said first andsecond opposite containment ends of said assembly comprise one or moreprotrusions for holding a pen needle in said opening and preventingrotation of said pen needle.
 7. (canceled)
 8. The method as recited inclaim 15, wherein said slidable internal holder is configured to bemoved through said opening when a new pen needle is removed and lock ata forward position, and to create a space in said opening, opposite saidnew pen needle removal side and accessible from said interior surface ofsaid assembly, for a used pen needle to be inserted and stored. 9.-13.(canceled)
 14. The method as recited in claim 15, wherein said assemblyis constructed of one or more of a polycarbonate, polyethylene,polypropylene and acrylonitrile butadiene styrene material.
 15. A methodfor storing both new and used pen needles of an injection apparatus in asingle storage assembly, comprising the steps of: removing a cover toaccess a new pen needle secured within an opening of said assembly;attaching said new pen needle to a drug delivery pen, wherein said newpen needle is releasably secured within said opening and prevented fromrotating; and pulling the new pen needle from one end of said opening toremove the new pen needle, wherein such removal motion serves to pull aslidable internal holder within the assembly forward, thereby creating aspace at an opposite end of said opening for the subsequent used penneedle to be inserted and stored.
 16. The method as recited in claim 15,further comprising the steps of: opening said assembly at a hinged pointbetween opposite first and second containment ends to allow interioraccess to said opposite end of said opening for receiving and storingthe used pen needle; inserting said used pen needle into said oppositeend of said opening, engaging said anti-rotation feature, and unscrewingsaid pen injection device from said used pen needle, and leaving saidused pen needle in said opening of said assembly; and closing saidassembly for storage. 17.-20. (canceled)